ArticleBritish journal of cancer2018
Strategies for clinical development of monoclonal antibodies beyond first-in-human trials: tested doses and rationale for dose selection.
Article in British journal of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed.
- Semi-Mechanistic Modeling of S-531011, a Humanized Anti-CCR8 Monoclonal Antibody, for Prediction of CCR8 Receptor Occupancy in Human Tumor Tissues.CPT: pharmacometrics & systems pharmacology · 2026Article
- Dose finding in early-phase human immunodeficiency virus type 1 prevention monoclonal antibody clinical trials.Clinical trials (London, England) · 2025Review
- In vitro Stability Study of a Panel of Commercial Antibodies at Physiological pH and Temperature as a Guide to Screen Biologic Candidate Molecules for the Potential Risk of In vivo Asparagine Deamidation and Activity Loss.Pharmaceutical research · 2025Article
- Comparison of monoclonal antibody disposition predictions using different physiologically based pharmacokinetic modelling platforms.Journal of pharmacokinetics and pharmacodynamics · 2024Article
- The Hammersmith Score Optimises Patient Selection and Predicts for Overall Survival in Early-Phase Cancer Trial Participants Independent of Tumour Burden.Chemotherapy · 2024Article
- Article
- Using an animal model to predict the effective human dose for oral multiple sclerosis drugs.Clinical and translational science · 2023Article
- Utilization of genetic information for medicines development and equitable benefit sharing.Frontiers in genetics · 2023Article
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging for the Prediction of Monoclonal Antibody Tumor Disposition.International journal of molecular sciences · 2022Article
- Clinically relevant dosing and pharmacokinetics of DNA-encoded antibody therapeutics in a sheep model.Frontiers in oncology · 2022Article
- Review
- Biopharmaceutics 4.0, Advanced Pre-Clinical Development of mRNA-Encoded Monoclonal Antibodies to Immunosuppressed Murine Models.Vaccines · 2021Article
- Which factors matter the most? Revisiting and dissecting antibody therapeutic doses.Drug discovery today · 2021Review
- Setting the Dose of Checkpoint Inhibitors: The Role of Clinical Pharmacology.Clinical pharmacokinetics · 2020Review
- Immuno-PET to Optimize the Dose of Monoclonal Antibodies for Cancer Therapy: How Much Is Enough?Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2019Article
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOur previous survey on first-in-human trials (FIHT) of monoclonal antibodies (mAbs) showed that, due to their limited toxicity, the recommended phase II dose (RP2D) was only tentatively defined.
methodsWe identified, by MEDLINE search, articles on single-agent trials of mAbs with an FIHT included in our previous survey. For each mAb, we examined tested dose(s) and dose selection rationale in non-FIHTs (NFIHTs). We also assessed the correlation between doses tested in the registration trials (RTs) of all FDA-approved mAbs and the corresponding FIHT results.
resultsIn the 37 dose-escalation NFIHTs, the RP2D indication was still poorly defined. In phase II-III NFIHTs (n=103 on 37 mAbs), the FIHT RP2D was the only dose tested for five mAbs. For 16 mAbs, only doses different from the FIHT RP2D or the maximum administered dose (MAD) were tested and the dose selection rationale infrequently indicated. In the 60 RTs on 27 FDA-approved mAbs with available FIHT, the FIHT RP2D was tested only for two mAbs, and RT doses were much lower than the FIHT MAD.
conclusionsThe rationale beyond dose selection in phase II and III trials of mAbs is often unclear in published articles and not based on FIHT data.
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